Requirements: English
Company: Akkodis
Region: Ghent , Flanders
About us:
Akkodis is an organization with more than 1,000 engineering, scientific and digital experts in Belgium. Our mission is clear: create a smarter future together! We are a one-stop-shop for engineering, IT, Life Science, and new technologies. Our combined passion for talent and technology allows us to look at the world differently.
With our 360 offer we support companies in all sectors in implementing Smart Industry solutions, from the up and reskilling of entire teams to the delivery of complete projects. Our added value? We make incredible happen!
What do you do all day?
As a Team Leader of a Lab Equipment Qualification platform, you will manage and optimize day to day team way of working and performance. You will be responsible of a team, composed of ANS-ATS-CSV specialists, whose role will be overseeing QC Validation activities, starting from user definition in collaboration with business partners, to the final handover of laboratory equipment to the business, in partnership with QC validation teams from our customer. In addition to using your skills in CSV, and validation of analytical and/or Automated systems; this position will combine team leadership, project management, and ensuring regulatory compliance.
This position will lead you to work closely with a Akkodis Service Manager, interact with different stakeholders within our client, as well as ensuring the monitoring and support of all team members. It''s a hybrid job that will allow you to combine work at home and on customer site of a global biopharmaceutical company.
Your responsibilities:
As Team leader, you are in charge to:
- Lead and oversee CSV/ANS/ATS validation activities for QC laboratory.
- Coach, train, and mentor your team on project-related topics.
- Monitor team workload and ensure deadlines and quality required are met.
- Plan and prioritize workloads, resources, and timelines to ensure efficient project execution.
- Continuously assess and adapt workflows to enhance performance and the quality of deliverables.
- Ensure compliance with international regulations and internal procedures.
- Be able to perform CSV/ANS/ATS validation activities (if needed).
- Be able to perform technical review of validation documentation (if needed).
- Provide support to our client for ensuring the capture of business needs Right First Time and act as the primary partner of Business Partner & QC Validation Head by contributing to strategical discussion.
- Ensure the achievement of KPis.
- Stay up to date with the latest standards and technologies related to the management and validation of Analytical and Automated systems, to be a driving force for continuous improvement.
- Participate to relevant governance and project review meeting to provide visibility of activities progression.
- Participate to the administrative tasks of the team (complete follow-up files, continuous improvement, etc.) and weekly follow-up meetings.
Your profile:
- You have a bachelors or masters degree related to Life Sciences, Computer Science, Automation, Bioengineering or related study.
- You have strong experience in Analytical, Automated and/or Computer Systems validation.
- You have at least 5 years of experience in a pharmaceutical or regulated QC environment with a focus on delivering solution.
- You have excellent understanding of GxP regulations, 21 CFR Part 11, Eudralex Annex 11 or other international requirements.
- You are proficiency in French and English, both written and spoken.
- You have proven experience as Project and/or Team Coordinator.
- You have an excellent leadership and team management abilities.
- You have strong communication skills to engage and align with stakeholders at all levels.
- You have ability to prioritize and multitask in a fast-paced environment.
- You have a problem-solving mindset and adaptability to handle unexpected challenges.
- You are proactive approach to decision-making and resource allocation.
- You have the capacity to coach, inspire, and develop team members.
- Which can be seen as a plus:
You master Microsoft Office Suite (especially, Excel).
You already have experience using SAP, Veeva, Klaro and/or Kneat.
You have knowledge in reporting/data management tools.
You have experience in QC laboratory environment and use of analytical equipment.
Whats the offer you cant refuse?
As an AKKODIS Team member, you will be:
- Onboarded in your position via a buddy process and supported in your career by your Business Manager.
- Actor of your training plan and your personal and professional development.
- Benefit from a full time permanen